Fluorouracil in Treating Patients With Recurrent or Metastatic Bladder Cancer

Phase 2

Completed

• Conditions: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer

• Registration Number: NCT00003175
• Lead Sponsor: Medical Research Council

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of fluorouracil given as a continuous infusion in treating patients with recurrent or metastatic bladder cancer.

Detailed Description

OBJECTIVES: I. Determine the response rate and toxic effects of continuous fluorouracil in patients with recurrent locally advanced or metastatic transitional cell urinary tract carcinoma. II. Determine the feasibility of this treatment in this patient population.

OUTLINE: Patients receive continuous intravenous fluorouracil by a Baxter Infusor for 24 weeks. Patients are evaluated for complete and partial response at 8, 16, and 24 weeks after the start of intravenous fluorouracil. Patients experiencing disease progression or unacceptable toxic effects are removed from the study. Patients are followed monthly for 6 months post treatment.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued.

Study Timeline

• Study Start: 1997-12
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-04-29
• Study First Posted: 2004-04-30
• Study Completion: 2009-03
• Status Verified: 2010-02
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (62)

Porto Alegre Hospital; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil

Cancer Care Ontario-London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Mount Sinai Hospital - Toronto; 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Hopital Sainte Justine; 🇨🇦 Montreal, Quebec, Canada

Maria Hospital; 🇫🇮 Helsinki, Finland

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Groote Schuur Hospital, Cape Town; 🇿🇦 Cape Town, South Africa

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